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Coroflex® ISAR NEO PMCF Study

Recruitingn/aAges 18 Years - anyAllFundación EPIC
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In plain words

What the trial is, and whether it could suit you

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: Coroflex® ISAR NEO is intended to be used for * Patients must be at least 18 years of age AND * The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND * Patients with Novo lesion length 2-4 mm AND * Informed consent signed Exclusion Criteria: * Patients with express refusal by the patient to participate in the study. * Patients pregnant women and lactating women. * Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4). * Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated * Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation * Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent * Patients with known sensitivity to contrast agents who cannot be premedicated. * Patients with contraindications or hypersensitivity to sirolimus * Patients with a life expectancy of less than 2 years * Patients included in other clinical trials
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What it tests

  • Coroflex® ISAR NEO coronary stent system
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Where

26 sites
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Centre Hospitalier Ajaccio
Ajaccio, France
CH Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
University Hospital Center of Caen
Caen, France
Hôpital Albert Schweitzer
Colmar, France
Hospitalario Universitario (CHU) de Lille
Lille, France
APHP -Hôpital Lariboisière
Paris, France
Clinique Saint-Hilaire
Rouen, France

…and 18 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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